StrokeParisKNCT01709045
ParisK: Correlation of Imaging Techniques With Histology
An observational study of Stroke and Plaque, Atherosclerotic, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The possibility to identify the risk of rupture of a carotid plaque will have tremendous impact in clinical decision making. A vulnerable plaque is considered to have a large lipid rich necrotic core (LRNC), a thin fibrous cap, the presence of inflammatory cells, intraplaque haemorrhage and/or neovascularisation (vasa… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Plaque, Atherosclerotic
- What is being tested?
- Magnetic Resonance Imaging (MRI), Dual-Energy Computed Tomography (DECT) and Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy, will be included.
Who may be able to join
- Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy
- Age 18 years or older (no maximum age)
- Informed consent by signing informed consent form regarding this study
- Symptomatic carotid artery stenosis 70-99% within 3 months of neurological symptoms
- Symptomatic carotid artery stenosis 50-99% in man within 2 weeks of neurological symptoms
- Asymptomatic carotid artery stenosis 70-99% with contralateral occlusion
Who cannot join
- Severe co-morbidity, dementia or pregnancy
- Standard contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia, etc.)
- Patients who have a documented allergy to MRI or CT contrast media
- Patients with a renal clearance <30 ml/min are not eligible to undergo contrast-enhanced MRI
- Patients with a renal clearance <60 ml/min are not eligible to undergo CT
- Surgery planned within 4 days of inclusion
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg
About this study
Official title: The Assessment of the Plaque at RISK by Non-invasive (Molecular) Imaging and Modelling (ParisK): Correlation of Imaging Techniques With Histology
The possibility to identify the risk of rupture of a carotid plaque will have tremendous impact in clinical decision making. A vulnerable plaque is considered to have a large lipid rich necrotic core (LRNC), a thin fibrous cap, the presence of inflammatory cells, intraplaque haemorrhage and/or neovascularisation (vasa vasorum). The investigators aim to validate imaging of plaque vulnerability with histology. Previous studies have evaluated the use of imaging to assess carotid plaque vulnerability, mostly showing a good correlation between imaging and histology and/or clinical characteristics. However, they have focused on single modalities, (magnetic resonance imaging [MRI], multidetector-row computed tomography (MDCT), ultrasonography (US) or transcranial Doppler (TCD), and have used relatively small cohorts
The primary goal of this study is to investigate whether there is a correlation between neovascularisation in the carotid atherosclerotic plaque as observed with 3.0 Tesla dynamic contrast-enhanced MRI and histology. Moreover, the investigators aim to investigate the correlation between the volume of the LRNC as determined by dual-energy CT and histology.
Read more
Secondly, the investigators will investigate the correlation between the volume of the LRNC, the fibrous cap status and the volume of the calcifications determined by MRI versus histology, the correlation between number of microembolisms and fibrous cap status and the correlation between the deformation pattern seen with ultrasound and the volume of the LRNC.
The imaging parameters showing good correlation with plaque vulnerability characteristics can be used for further analysis in assessing the vulnerable plaque
- Conditions
- Stroke, Plaque, Atherosclerotic
- Being tested
- Magnetic Resonance Imaging (MRI), Dual-Energy Computed Tomography (DECT), Ultrasound, Transcranial doppler
- Keywords
- Endarterectomy, Carotid, Carotid Arteries
- Medical subject headings
- Stroke, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Other
Also called 3.0 T Philips Achieva
Multi-sequence MR protocol
Dual-Energy Computed Tomography (DECT)Radiation
Also called Siemens Flash
UltrasoundOther
Also called Philips IU22
Transcranial dopplerOther
Also called Hemodynamics AG
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for CEA | All patients who are scheduled for carotid endarterectomy (CEA) Receives: Other: Magnetic Resonance Imaging (MRI); Radiation: Dual-Energy Computed Tomography (DECT); Other: Ultrasound; Other: Transcranial doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ktrans on dynamic contrast-enhanced (DCE)-MRI
The correlation between neovascularisation in carotid atherosclerotic plaque as assessed by dynamic 3.0 Tesla MRI and microvasculature as assessed by histology.
Measured: 1 day
Lipid-rich necrotic core on dual-energy CT
The correlation between the size of lipid-rich-necrotic-core in dual-energy CT and histology.
Measured: 1 day
Secondary outcomes (3)
deformation pattern on ultrasound
The correlation between deformation pattern at echo and plaque composition (volume of LRNC) at histology.
Measured: 1 day
number of recorded micro embolic signals (MES)
The relation between number of recorded MES and fibrous cap status at histology.
Measured: 1 day
Volume of LRNC and calcifications and fibrous cap status on MRI
The correlation between volume of LRNC, fibrous cap status and volume of calcifications in carotid atherosclerotic plaques visualised by MRI and the same features as determined at histology.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startAug 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Translational Molecular Medicine, Dutch Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Eline Kooi, PhD, Study chair, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709045
- Sponsor's protocol ID
- 10-2-048
- Acronym
- ParisK
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2012
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Aizaz M, Bierens J, Gijbels MJJ, Schreuder THCML, van Orshoven NP, Daemen JHC, Mess WH, Flohr T, van Oostenbrugge RJ, Postma AA, Kooi ME. Differentiation of Atherosclerotic Carotid Plaque Components With Dual-Energy Computed Tomography. Invest Radiol. 2025 Aug 1;60(8):508-516. doi: 10.1097/RLI.0000000000001153. Epub 2025 Jan 22.
PubMed 39836610Crombag GAJC, Schreuder FHBM, van Hoof RHM, Truijman MTB, Wijnen NJA, Voo SA, Nelemans PJ, Heeneman S, Nederkoorn PJ, Daemen JH, Daemen MJAP, Mess WH, Wildberger JE, van Oostenbrugge RJ, Kooi ME. Microvasculature and intraplaque hemorrhage in atherosclerotic carotid lesions: a cardiovascular magnetic resonance imaging study. J Cardiovasc Magn Reson. 2019 Mar 4;21(1):15. doi: 10.1186/s12968-019-0524-9.
PubMed 30832656Truijman MT, de Rotte AA, Aaslid R, van Dijk AC, Steinbuch J, Liem MI, Schreuder FH, van der Steen AF, Daemen MJ, van Oostenbrugge RJ, Wildberger JE, Nederkoorn PJ, Hendrikse J, van der Lugt A, Kooi ME, Mess WH; Plaque at RISK Study. Intraplaque hemorrhage, fibrous cap status, and microembolic signals in symptomatic patients with mild to moderate carotid artery stenosis: the Plaque at RISK study. Stroke. 2014 Nov;45(11):3423-6. doi: 10.1161/STROKEAHA.114.006800. Epub 2014 Sep 25.
PubMed 25256179
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of the Plaque at RISK by Non-invasive (Molecular) Imaging and Modelling (ParisK): Correlation of Imaging Techniques With Histology
- ClinicalTrials.gov ID
- NCT01709045
- Acronym / sponsor ID
- ParisK / 10-2-048
- Conditions
- Stroke, Plaque, Atherosclerotic
- Keywords
- Endarterectomy, Carotid, Carotid Arteries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Center for Translational Molecular Medicine, Dutch Heart Foundation
- Study start
- Aug 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The possibility to identify the risk of rupture of a carotid plaque will have tremendous impact in clinical decision making. A vulnerable plaque is considered to have a large lipid rich necrotic core (LRNC), a thin fibrous cap, the presence of inflammatory cells, intraplaque haemorrhage and/or neovascularisation (vasa vasorum). The investigators aim to validate imaging of plaque vulnerability with histology. Previous studies have evaluated the use of imaging to assess carotid plaque vulnerability, mostly showing a good correlation between imaging and histology and/or clinical characteristics. However, they have focused on single modalities, (magnetic resonance imaging [MRI], multidetector-row computed tomography (MDCT), ultrasonography (US) or transcranial Doppler (TCD), and have used relatively small cohorts
The primary goal of this study is to investigate whether there is a correlation between neovascularisation in the carotid atherosclerotic plaque as observed with 3.0 Tesla dynamic contrast-enhanced MRI and histology. Moreover, the investigators aim to investigate the correlation between the volume of the LRNC as determined by dual-energy CT and histology.
Secondly, the investigators will investigate the correlation between the volume of the LRNC, the fibrous cap status and the volume of the calcifications determined by MRI versus histology, the correlation between number of microembolisms and fibrous cap status and the correlation between the deformation pattern seen with ultrasound and the volume of the LRNC.
The imaging parameters showing good correlation with plaque vulnerability characteristics can be used for further analysis in assessing the vulnerable plaque
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for CEA | – | Other: Magnetic Resonance Imaging (MRI), Radiation: Dual-Energy Computed Tomography (DECT), Other: Ultrasound, Other: Transcranial dopplerAll patients who are scheduled for carotid endarterectomy (CEA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy, will be included.
Key inclusion criteria (6 listed)
- Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy
- Age 18 years or older (no maximum age)
- Informed consent by signing informed consent form regarding this study
Key exclusion criteria (6 listed)
- Severe co-morbidity, dementia or pregnancy
- Standard contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia, etc.)
- Patients who have a documented allergy to MRI or CT contrast media
- Patients with a renal clearance <30 ml/min are not eligible to undergo contrast-enhanced MRI
- Patients with a renal clearance <60 ml/min are not eligible to undergo CT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Also: 3.0 T Philips AchievaMulti-sequence MR protocol | Other | Patients scheduled for CEA |
| Dual-Energy Computed Tomography (DECT)Also: Siemens Flash | Radiation | Patients scheduled for CEA |
| UltrasoundAlso: Philips IU22 | Other | Patients scheduled for CEA |
| Transcranial dopplerAlso: Hemodynamics AG | Other | Patients scheduled for CEA |
Primary outcome
Ktrans on dynamic contrast-enhanced (DCE)-MRI
Time frame: 1 day
The correlation between neovascularisation in carotid atherosclerotic plaque as assessed by dynamic 3.0 Tesla MRI and microvasculature as assessed by histology.
Lipid-rich necrotic core on dual-energy CT
Time frame: 1 day
The correlation between the size of lipid-rich-necrotic-core in dual-energy CT and histology.
3 secondary outcomes
deformation pattern on ultrasound
Time frame: 1 day
number of recorded micro embolic signals (MES)
Time frame: 1 day
Volume of LRNC and calcifications and fibrous cap status on MRI
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Derived from this study: PubMed 39836610Aizaz M, Bierens J, Gijbels MJJ, Schreuder THCML, van Orshoven NP, Daemen JHC, Mess WH, Flohr T, van Oostenbrugge RJ, Postma AA, Kooi ME. Differentiation of Atherosclerotic Carotid Plaque Components With Dual-Energy Computed Tomography. Invest Radiol. 2025 Aug 1;60(8):508-516. doi: 10.1097/RLI.0000000000001153. Epub 2025 Jan 22.
- Derived from this study: PubMed 30832656Crombag GAJC, Schreuder FHBM, van Hoof RHM, Truijman MTB, Wijnen NJA, Voo SA, Nelemans PJ, Heeneman S, Nederkoorn PJ, Daemen JH, Daemen MJAP, Mess WH, Wildberger JE, van Oostenbrugge RJ, Kooi ME. Microvasculature and intraplaque hemorrhage in atherosclerotic carotid lesions: a cardiovascular magnetic resonance imaging study. J Cardiovasc Magn Reson. 2019 Mar 4;21(1):15. doi: 10.1186/s12968-019-0524-9.
- Derived from this study: PubMed 25256179Truijman MT, de Rotte AA, Aaslid R, van Dijk AC, Steinbuch J, Liem MI, Schreuder FH, van der Steen AF, Daemen MJ, van Oostenbrugge RJ, Wildberger JE, Nederkoorn PJ, Hendrikse J, van der Lugt A, Kooi ME, Mess WH; Plaque at RISK Study. Intraplaque hemorrhage, fibrous cap status, and microembolic signals in symptomatic patients with mild to moderate carotid artery stenosis: the Plaque at RISK study. Stroke. 2014 Nov;45(11):3423-6. doi: 10.1161/STROKEAHA.114.006800. Epub 2014 Sep 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eline Kooi, PhD study chair
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Plaque, Atherosclerotic, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ktrans on dynamic contrast-enhanced (DCE)-MRI (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01709045, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.